Group Regulatory Affairs Manager

工作内容

Ontex is a leading international producer of personal hygiene solutions for babies, women and adults. We distribute in more than 110 countries through leading retailer private labels, as well as under our own brands. The group employs over 10,000 employees, spread around the world. Ontex is listed on Euronext Brussels.Our people are our most valuable asset. To support and reinforce our R&D team we are looking for a Group Regulatory Affairs Manager.The Group Regulatory Affairs (RA) Manager understands and translates global regulatory, scientific, operational and business knowledge into effective product regulatory strategies and implementation plans for Ontex’s therapeutic goods and medical devices.The Group RA Manager responsibilities include but are not limited to

• Keep abreast of regulatory changes and developments and advise senior management on potential impact to the business
• Develop and implement regulatory strategies for medical device products in accordance with global regulations and guidelines.
• Provide guidance to cross-functional teams on regulatory requirements, including clinical trial requirements, labeling, and advertising and promotion.
• Review and assess regulatory submissions, including 510(k) and CE Mark applications, and other global regulatory submissions.
• Serve as the primary contact for regulatory agencies and manage regulatory inspections and audits.
• Lead and manage the regulatory affairs team and vendors, including hiring and training of staff, as well as providing guidance and direction on regulatory issues.

Profile

• Master’s degree (university or equal through experience) in science
• Minimum of 8 years experience in Regulatory Affairs for medical devices
• Extensive experience with EU and US regulatory requirements for medical devices
• Knowledge of good clinical practice (GCP) and appropriate regional clinical research guidelines
• Knowledge of medical device standards such as ISO 13485 and ISO 14971.
• Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
• Certifications in regulatory affairs like RAC are an asset
• Experience as a Person Responsible for Regulatory Compliance is an asset.
• Experience in working with cross-functional teams and building strong relationships across departments
• Proven project management skills in cross-functional teams
• Fluent in English or any other language is considered an asset

Interested in a job at Ontex, but still have a question? Contact our HR department (